Medical device licence · 105231 · Class 2
HYDRASENSE ULTRA
Yes: licensed in Canada
Licence status Issued (active); first licensed September 29, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105231
- Licence holder
- Bayer Inc.Elkhart, Indiana, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 29, 2020
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HYDRASENSE ULTRA
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “hydrasense”. A notice may cover another product or only some lots: read it to see what it covers.
- Hydrasense Baby Nasal Care EasydoseMay 2, 2024 · Ear, nose and throat · Sterility · Type I
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.